Company ยท US
Respironics Inc., Sleep & Home Respiratory Group
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2010. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2010 | K092835 | COMFORTGEL NASAL MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Dec 18, 2009 | K092648 | RESPIRONICS PERFORMAX SE TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | CBK |
| Oct 30, 2009 | K090539 | BIPAP AUTOSV ADVANCED Respironics Inc., Sleep & Home Respiratory Group | MNS |
| Oct 23, 2009 | K091191 | GAS TRANSFILL Respironics Inc., Sleep & Home Respiratory Group | CAW |
| Sep 10, 2009 | K091843 | COMFORT TWIN NASAL MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Sep 3, 2009 | K091066 | COMFORT TWIN NASAL MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Aug 3, 2009 | K091319 | REMSTAR AUTO A-FLEX Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Jun 26, 2009 | K090484 | ALICE PDX Respironics Inc., Sleep & Home Respiratory Group | MNR |
| May 29, 2009 | K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| May 8, 2009 | K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Mar 13, 2009 | K083526 | TRILOGY 100 VENTILATOR Respironics Inc., Sleep & Home Respiratory Group | CBK |
| Mar 4, 2009 | K090248 | BIPAP AUTOSV Respironics Inc., Sleep & Home Respiratory Group | MNS |
| Jan 30, 2009 | K082866 | REVOLUTIONFULL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Jan 26, 2009 | K083874 | GALAXY Respironics Inc., Sleep & Home Respiratory Group | MNR |
| Apr 25, 2008 | K073600 | COMFORTGEL FULL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Dec 19, 2007 | K072592 | PERFORMAX TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | BZD |
| Dec 18, 2007 | K072588 | PERFORMAX SE TOTAL FACE MASK Respironics Inc., Sleep & Home Respiratory Group | CBK |
| Aug 8, 2007 | K071509 | BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM Respironics Inc., Sleep & Home Respiratory Group | MNS |
| May 18, 2007 | K070180 | WALLABY 4 Respironics Inc., Sleep & Home Respiratory Group | LBI |
| May 8, 2007 | K070328 | BIPAP SYNCHRONY WITH AVAPS Respironics Inc., Sleep & Home Respiratory Group | MNS |
| Mar 9, 2007 | K063830 | REMSTAR AFLEX CPAP SYSTEM Respironics Inc., Sleep & Home Respiratory Group | BZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||